Discretionary Denial: Even the “Best” Prosecution Prior Art May Not Be Right for an IPR

Posted by Josh Miller on Feb 7, 2018

A pair of recent PTAB institution decisions highlights that petitioners should be cautious when relying on prior art that was cited during the prosecution of the challenged patent. Pursuant to 35 U.S.C. § 325(d), the PTAB has the discretion to deny institution if the petition relies on prior art or arguments that the examiner already addressed during patent prosecution. In two recent decisions that issued just one day apart and reached opposite conclusions, the PTAB provided some insight into circumstances that may lead to (or away from) a discretionary denial.

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PTAB Left to Mitigate the Damage from Collateral Estoppel

Posted by Nathan Speed on Jan 30, 2018

Nathan Speed

Collateral estoppel, or issue preclusion, is the legal doctrine that bars a litigant from re-litigating in subsequent litigations an issue that it lost in an earlier litigation. The doctrine had been applied in the administrative context previously, and in Maxlinear, Inc. v. CF Crespe, the Federal Circuit confirmed that it applies in IPR proceedings. In doing so, however, the court left the Board to resolve an interesting practical question as to how exactly collateral estoppel should apply on remand. Depending on how the Board resolves this practical issue, Maxlinear may provide petitioners a significant windfall as they will be able to challenge claims on the basis of prior art that they never cited to the Board. 

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Topics: IPR Estoppel

For PTAB Declarations, Better to Fly Solo

Posted by John Strand on Jan 22, 2018

John Strand

Many things in life are better done with someone else: board games, dinner parties, road trips, riding tandem bicycles. However, according to the PTAB, there’s one particular area where it’s best to fly solo: two people should not provide one declaration in an IPR. In CSL Behring GMBH v. Shire Viropharma Inc. (IPR2017-01512), the PTAB denied institution in large part because the petitioner submitted a joint declaration to support that one of its references was a printed publication.

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Topics: Printed Publications

Proving Them Wrong: FDA Skepticism Helps Save Patent Claims

Posted by Phil Hamzik on Jan 17, 2018

Phil Hamzik

Evidence of skepticism of others in an IPR can be used to support the patentability of claims in response to obviousness challenges—skepticism is a standard “objective indicia” or secondary consideration of nonobviousness. In a recent series of IPRs filed by several generic drug makers against Eli Lilly & Co. (IPR2016-00318, IPR2016-00237 and IPR2016-00240), Eli Lilly bolstered its case for nonobviousness by pointing to the skepticism of the U.S. Food & Drug Administration (FDA) concerning its patented method. The PTAB’s decision illustrates that while skepticism by some may be helpful to patent owners, skepticism by the right people may be critical.

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Topics: BioPharma, Obviousness

One Missing Link Can Break an Obviousness Argument

Posted by Jillian Parker on Jan 15, 2018

Jillian Parker

IPRs are often filed to challenge important patents – the same patents likely to be tested in litigation. In such circumstances, parties should pay careful attention when asserting arguments in the IPR that were addressed in the litigation. Several generic drug makers faced this circumstance in relation to obviousness arguments made in a series of IPRs against Eli Lilly & Co. (IPR2016-00318, IPR2016-00237 and IPR2016-00240), in which similar arguments made in a co-pending appeal before the Federal Circuit were found to be lacking. While the PTAB is not required to agree with courts on all issues, particularly in view of the fact that the standards of review between the two venues are different, these IPRs illustrate that petitioners and patent owners would be wise to carefully address what courts have said about the arguments at issue.

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Topics: BioPharma, Obviousness

Tipping the Scales in IPR with Effective Expert Testimony

Posted by William Zhang on Jan 10, 2018

William Zhang

Expert testimony is a feature of most IPRs, and effective expert testimony can make or break a party’s position. When evaluating expert testimony, the PTAB may consider several issues. First, are the expert’s qualifications sufficient? Second, even if the expert does not technically qualify as a “person of ordinary skill in the art,” should the expert’s testimony be given weight? The PTAB’s decision in Lupin Ltd. v. Horizon Therapeutics, Inc. (IPR2016-00829) addresses these questions and illustrates several ways to effectively use expert testimony.

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Topics: BioPharma, Experts

PTAB Says Yes to (Pro)Drugs

Posted by Jessica Chao on Dec 18, 2017

Jessica Chao

Prodrugs are inactive compounds designed to be converted into pharmaceutically active metabolites following delivery to a patient. Prodrugs have important pharmacokinetic advantages over traditional compounds, and a recent PTAB decision, Lupin Limited v. Vertex Pharmaceuticals Inc. (IPR2016-00558), illustrates how prodrugs can possess patent advantages as well. In its analysis of obviousness, the PTAB focuses on unpredictable results and whether a person of ordinary skill in the art has a reasonable expectation of success in view of the available art, as outlined in Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009), frequently applied in pharmaceutical cases.

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Topics: BioPharma, Obviousness

Supreme Court May Let IPRs Continue

Posted by Elizabeth Hudson on Dec 8, 2017

Elizabeth Hudson

Last week, the Supreme Court heard oral arguments in Oil States Energy Services v. Greene’s Energy Group—a case that addresses whether inter partes review unconstitutionally usurps the federal courts’ authority to adjudicate the validity of patents. An examination of the Justices’ questions provides hints of how they are thinking and suggests that IPRs may survive constitutional review.

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Topics: Petitioners, Patent Owners

PTAB Continues to Draw a Hard Line on Printed Publications

Posted by Marie McKiernan on Dec 6, 2017

Marie McKiernan

As we discussed in May, PTAB decisions are a primary source for guidance regarding what constitutes a “printed publication” under § 102, because the PTAB faces the issue so frequently.  Since that post, the PTAB has continued to define the scope of what is or is not a printed publication. In most instances, where the issue was contested, the PTAB found the petitioner failed to prove a document was a printed publication.                                                                                                 

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Topics: Printed Publications

Supreme Court Suggests a Partial Solution to Partial Institutions

Posted by Elizabeth Hudson on Dec 4, 2017

Elizabeth Hudson

Last week, the U.S. Supreme Court heard oral arguments in two patent cases concerning IPRs. The first case (Oil States Energy Services v. Greene’s Energy Group) has garnered much of the attention because it concerns the constitutionality of IPRs, but the second case (SAS Institute Inc. v. Matal) may actually have a bigger impact on how IPRs work. In SAS, the Supreme Court considered the PTAB’s practice of selecting which challenged claims it reviews, rather than, once it institutes a trial, issuing a final decision on the patentability of all claims challenged in the petition. The oral arguments suggest how the Justices are approaching the case.

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Topics: Petitioners, Patent Owners

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This blog is intended to promote thought and debate on developing areas of the law. The opinions, commentary and characterizations of cases provided on this blog are not legal advice and do not represent the opinions of Wolf Greenfield or its clients.